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Abstract:

An apparatus for steering a guidewire and for connecting the guidewire to
an extension guidewire. The apparatus includes a steering device for
gripping an exterior of the guidewire, the steering device defining a
passageway therein through which the guidewire may pass; and a connecting
device for connecting the guidewire to the extension guidewire. The
connecting device is configured for mating with the steering device to
form an integral unit. The invention further includes a method of
inserting a guidewire in a body and connecting the guidewire to an
extension guidewire. The method includes the steps of: providing an
integral guidewire holder and tool for connecting a guidewire to an
extension guidewire; gripping the guidewire with the integral guidewire
holder; inserting the guidewire into a body lumen; displacing the
integral guidewire holder and tool relative to the guidewire so that the
proximal end of the guidewire is located in a slot of the integral
guidewire holder and tool; inserting an extension guidewire into the slot
of the integral guidewire holder and tool; and connecting the guidewire
to the extension guidewire. The method further includes the step of
aligning the guidewire and extension guidewire in the slot prior to the
connecting step.

Claims:

1-27. (canceled)

28. An apparatus for steering a guidewire and for connecting the guidewire
to an extension guidewire, comprising:a steering device configured to
grip the guidewire, the steering device including a passageway therein
configured to receive the guidewire; anda connecting device configured to
connect the guidewire to the extension guidewire, wherein said connecting
device and said steering device share a common longitudinal axis, said
connecting device configured to slidably mate with said steering device
to form an integral unit.

29. The apparatus of claim 28, wherein said steering device includes a
plurality of prongs configured to grip the guidewire.

30. The apparatus of claim 28, wherein said connecting device includes a
longitudinal slot for aligning the guidewire with the extension
guidewire.

31. The apparatus of claim 30, wherein a proximal end of the connecting
device farthest from the steering device includes a partial conical
opening for guiding the extension guidewire into the longitudinal slot.

33. The apparatus of claim 30, wherein a distal end of the connecting
device adjacent the steering device includes a conical opening for
guiding the guidewire into a passageway of the connecting device.

34. The apparatus of claim 33, wherein the passageway of said connecting
device transitions into the longitudinal slot at a tapered portion of
said connecting device

35. The apparatus of claim 34, wherein the tapered portion terminates at a
substantially flat surface, the longitudinal slot being located in the
substantially flat surface, the substantially flat surface including a
transverse channel intersecting said longitudinal slot.

36. The apparatus of claim 35, wherein a first wall of the transverse
channel is higher than a second wall of the transverse channel.

37. The apparatus of claim 29, wherein the steering device includes an
outer member and an inner member, the outer member including a gripping
portion and a prong-engaging portion, the inner member including a
proximal cylindrical portion, a central cylindrical portion, a distal
cylindrical portion, and the plurality of prongs.

38. The apparatus of claim 37, wherein the outer member is positioned
around an exterior of at least a portion of the central cylindrical
portion, the distal cylindrical portion, and the plurality of prongs.

39. The apparatus of claim 38, wherein the outer member and the inner
member share a common axis and are slidable relative to one another, and
an axial sliding of the outer member causes an inner surface of the
prong-engaging portion to interfere with an outer surface of the
plurality of prongs, causing the plurality of prongs to move toward each
other.

40. The apparatus of claim 28, wherein the passageway of said steering
device tapers to become progressively larger as it approaches an end of
said steering device that mates with said connecting device.

41. An apparatus for steering a guidewire and for connecting the guidewire
to an extension guidewire, comprising:a steering device configured to
grip the guidewire, the steering device including a passageway therein
configured to receive the guidewire; anda connecting device configured to
connect the guidewire to the extension guidewire, wherein said connecting
device includes a passageway configured to receive the guidewire, the
passageway of the steering device and the passageway of the connecting
device being substantially adjacent and coaxial, said connecting device
configured to mate with said steering device to form an integral unit.

42. The apparatus of claim 41, wherein said passageway of the connecting
device extends to a longitudinal slot configured to align the guidewire
with the extension guidewire.

43. The apparatus of claim 42, wherein the slot is located in a
substantially flat surface, the substantially flat surface including a
transverse channel intersecting said longitudinal slot.

44. The apparatus of claim 43, wherein a first wall of the transverse
channel is higher than a second wall of the transverse channel.

45. The apparatus of claim 41, wherein the connecting device includes a
cylindrical outer surface configured to slidably mate with a cylindrical
inner surface of the steering device.

46. The apparatus of claim 41, wherein said steering device includes a
plurality of prongs configured to grip the guidewire.

47. The apparatus of claim 41, wherein a distal end of the connecting
device adjacent the steering device includes a conical opening for
guiding the guidewire into the passageway of the connecting device.

48. The apparatus of claim 46, wherein the steering device includes an
outer member and an inner member, the outer member including a gripping
portion and a prong-engaging portion, the inner member including a
proximal cylindrical portion, a central cylindrical portion, a distal
cylindrical portion, and the plurality of prongs.

49. The apparatus of claim 48, wherein the outer member and the inner
member share a common axis and are slidable relative to one another, and
an axial sliding of the outer member causes an inner surface of the
prong-engaging portion to interfere with an outer surface of the
plurality of prongs, causing the plurality of prongs to move toward each
other.

50. An apparatus for steering a guidewire and for connecting the guidewire
to an extension guidewire, comprising:a steering device configured to
grip the guidewire, the steering device including a passageway therein
configured to receive the guidewire; anda connecting device configured to
connect the guidewire to the extension guidewire, said connecting device
being configured to mate with said steering device along a common axis to
form an integral unit, wherein said connecting device includes a
longitudinal slot for aligning the guidewire with the extension
guidewire.

51. The apparatus of claim 50, wherein the slot is located in a
substantially flat surface, the substantially flat surface including a
transverse channel intersecting said longitudinal slot.

52. The apparatus of claim 50, wherein the steering device includes an
outer member and an inner member, the outer member including a gripping
portion and a prong-engaging portion, the inner member including a
proximal cylindrical portion, a central cylindrical portion, a distal
cylindrical portion, and a plurality of prongs.

53. The apparatus of claim 52, wherein the outer member and the inner
member share a common axis and are slidable relative to one another, and
an axial sliding of the outer member causes an inner surface of the
prong-engaging portion to interfere with an outer surface of the
plurality of prongs, causing the plurality of prongs to move toward each
other.

Description:

BACKGROUND OF THE INVENTION

[0001]1. Field of the Invention

[0002]This invention relates to an apparatus and method for manipulating a
guidewire and connecting the guidewire to an extension guidewire.

[0003]2. Description of the Related Art

[0004]Medical guidewires generally are used for navigating through
internal passageways of a body. The distal end of a guidewire is
introduced into a body by a physician through an opening in the body. The
physician manipulates the tip of the guidewire through the body to a site
to be treated. A catheter or other medical device is usually advanced
over the guidewire to the treatment site. In some medical applications,
it is desirable to use multiple catheters sequentially in order to
complete the medical procedure. When it is necessary to change catheters,
it is usually preferred that the catheter be removed in a manner which
enables a guidewire to remain in place in the body so that the end of the
guidewire remains on the site to be treated. In order to maintain a
guidewire in place while withdrawing the catheter, the guidewire must be
gripped at its proximal end to prevent it from being pulled away from the
site to be treated, for example, a blood vessel. However, the guidewire
typically only extends for a short portion outside of the catheter which
is inserted in the body. Therefore, before the catheter is fully
withdrawn from the body, the catheter completely covers the proximally
extending end of the guidewire. As a result, there is no way in which to
grip the proximal end of the guidewire to hold it in place and prevent it
from being withdrawn together with the catheter.

[0005]One method which has been proposed for solving the above catheter
exchange problem is the use of an exchange wire. In such a method, the
existing guidewire is removed and replaced by a longer exchange wire. The
removal and replacement occurs with the existing catheter in place.
Unfortunately, the insertion of each additional wire significantly
increases the risk of trauma and puncture to the patient and extends the
duration of the procedure.

[0006]Another common method is the use of an extension guidewire. This has
improved the procedure for performing a catheter exchange. An extension
guidewire allows a catheter exchange to be made without any guidewire
exchanges. In this way, there is a significant reduction in risk of
puncturing blood vessels in the body, and a reduction in the time to
perform the procedure. However, current apparatus and methods for
steering the main guidewire into the body and then connecting the main
guidewire to an extension guidewire to perform a catheter exchange have
certain drawbacks.

[0007]Current extension guidewire methods require the use of a separate
apparatus for steering the main guidewire into the body and a separate
apparatus for aligning and connecting the main guidewire with an
extension guidewire. Typically, a torque vise or pin vise is provided for
gripping the main guidewire and steering the main guidewire into the
human body. The main guidewire is often provided with an angled tip so
that the operator can rotate the main guidewire and steer the main
guidewire through the body. The torque vise can be slid back along the
main guidewire to permit advancement of the main guidewire relative to
the torque vise in order to insert the main guidewire further into the
human body. Once the main guidewire and catheter are in place, it is
often necessary to perform a catheter exchange.

[0008]Typically, an alignment tool functions to connect the proximal end
of the in-situ guidewire to an extension guidewire. The torque vise is
first removed from the in-situ guidewire. The alignment tool is then
placed on the in-situ guidewire and used to align and connect the in-situ
guidewire with an extension guidewire. After the in-situ guidewire and
extension guidewire are connected, the alignment tool is removed. The
alignment tool is removed by sliding the alignment tool proximally over
the portion of the in-situ guidewire located in the alignment tool and
then over the extension guidewire. The existing catheter in the body is
then drawn proximally over the entire length of the in-situ and extension
guidewire, and then replaced by a new catheter by sliding the new
catheter distally over the entire length of the extension guidewire and
in-situ guidewire. The extension guidewire then can be disconnected once
the new catheter is in place.

[0009]This process of using a separate torque vise and alignment tool is
cumbersome and significantly increases the amount of time for performing
such operations. The amount of time spent on such operations can
significantly increase the risk to a patient. Moreover, the use of
separate apparatus for steering the main guidewire and for connecting the
main guidewire to an extension guidewire makes the operation more
complex, thus leading to more opportunities for mistakes or movement of
the in-situ main guidewire during a catheter exchange. In addition, each
tool must be separately manufactured, packaged and handled, increasing
cost, for example. Therefore, for the above reasons, the current
apparatus and methods for steering a main guidewire and connecting the
main guidewire to an extension guidewire are less than desirable. There
is a need for an apparatus and method for steering a main guidewire and
connecting the main guidewire to an extension guidewire which
substantially obviates these problems.

SUMMARY OF THE INVENTION

[0010]The advantages and purposes of the invention will be set forth in
part in the description which follows, and in part will be obvious from
the description, or may be learned by practice of the invention. The
advantages and purposes of the invention will be realized and attained by
means of the elements and combinations particularly pointed out in the
appended claims.

[0011]To attain the advantages and in accordance with the purposes of the
invention, as embodied and broadly described herein, the invention
includes an apparatus for steering a guidewire and for connecting the
guidewire to an extension guidewire. The apparatus includes a steering
device for gripping an exterior of the guidewire, the steering device
defining a passageway therein through which the guidewire may pass, and a
connecting device for connecting the guidewire to the extension
guidewire. The connecting device is configured for mating with the
steering device to form an integral unit.

[0012]In another aspect, the invention includes a method of inserting a
guidewire into a body and connecting the guidewire to an extension
guidewire. The method includes the steps of: providing an integral
guidewire holder and tool for connecting a guidewire to an extension
guidewire; gripping the guidewire with the integral guidewire holder;
inserting the guidewire into a body lumen using the integral guidewire
holder and tool; displacing the integral guidewire holder and tool
relative to the guidewire so that the proximal end of the guidewire is
located in a slot of the integral guidewire holder and tube; inserting an
extension guidewire into the slot of the integral guidewire holder and
tool; and connecting the guidewire to the extension guidewire.

[0013]It is to be understood that both the foregoing general description
and the following detailed description are exemplary and explanatory only
and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014]The accompanying drawings, which are incorporated in and constitute
a part of this specification, illustrate several embodiments of the
invention and together with the description, serve to explain the
principles of the invention. In the drawings,

[0015]FIG. 1 is a side view of an apparatus for steering a guidewire and
for connecting the guidewire to an extension guidewire according to an
embodiment of the invention;

[0016]FIG. 2 is a top view of the apparatus of FIG. 1 with a guidewire
inserted therethrough;

[0017]FIG. 3 is a side view of a steering device of the apparatus of FIG.
1;

[0018]FIG. 4 is a side view of the steering device of FIG. 3 with portions
removed;

[0019]FIG. 5 is an end view of the steering device of FIG. 3;

[0020]FIG. 6 is a cross-sectional view of the steering device of FIG. 3,
taken along line VI-VI of FIG. 5;

[0021]FIG. 7 is a top view of a connecting device of the apparatus of FIG.
1;

[0022]FIG. 8 is a side view of the connecting device of FIG. 7;

[0023]FIG. 9 is a perspective view of the connecting device of FIG. 7; and

[0024]FIG. 10 is an end view of the connecting device of FIG. 7.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025]Reference will now be made in detail to the present preferred
embodiments of the invention, examples of which are illustrated in the
accompanying drawings. Wherever possible, the same reference numbers will
be used throughout the drawings to refer to the same or like parts.

[0026]Throughout the specification and claims, the terms "proximal" and
"distal" are used to designate relative ends of components. These terms
are used in the same manner in which they are widely used and well
recognized by those knowledgeable in the field of medical procedures. The
"distal" end of the components refers to the end furthest inside the body
when in use and therefore furthest from the operator of the catheter or
guidewire, whereas "proximal" end refers to the opposite end, i.e., the
end closest to the operator.

[0027]In accordance with the present invention, an apparatus for steering
a guidewire and for connecting the guidewire to an extension guidewire is
provided. According to an embodiment of the invention, the apparatus
generally includes a steering device and a connecting device. The
steering device grips an exterior of the guidewire in order to steer the
guidewire. The steering device defines a passageway therein through which
a guidewire may pass. The connecting device connects the guidewire to an
extension guidewire. The connecting device is configured for mating with
the steering device to form a single integral unit. A method of steering
the guidewire and connecting the guidewire to an extendable guidewire is
also provided.

[0028]The apparatus for performing steering of a guidewire and connecting
the guidewire to an extension guidewire will be described below. As
embodied herein and shown in FIGS. 1-10, the apparatus 10 for steering a
guidewire 100 and for connecting the guidewire to an extension guidewire
includes a steering device 12 and a connecting device 14. The apparatus
10 is a single, integral unit which can be used for both steering a
guidewire through lumens of a body, and for connecting an extension
guidewire to the in-situ guidewire in order to perform a catheter
exchange. With the present invention, it is not necessary to completely
remove a torque vise from the guidewire prior to aligning and connecting
the guidewire with an extension guidewire, as will be apparent from the
following description. The provision of the steering device and
connecting device into a single, integral unit simplifies the procedure
for exchanging catheters, making the procedure quicker, safer, and less
expensive.

[0029]In accordance with the present invention, the steering device
manually grips the exterior of a guidewire in order to steer the
guidewire through the body. As embodied herein and shown in FIGS. 1-6,
the guidewire steering device 12 holds or grips an exterior of a
guidewire 100. A guidewire steering device or guidewire holder can be any
suitable device for holding onto a guidewire so that it can be
manipulated through the body. In the specific embodiment shown in the
drawings, the guidewire steering device or guidewire holder is a torque
device often referred to as a torque vise or pin vise.

[0030]The steering device 12 comprises a distal outer tubular member 15
and an inner member 18. The distal outer tubular member 15 includes a
proximal gripping portion 16 and a distal prong-engaging portion 17. The
proximal gripping portion 16 has grooves on the outer periphery thereof
for enhancing the ability of the operator to grip the distal outer
tubular member 15. The distal prong-engaging portion 17, in one
embodiment, has a smaller diameter than the proximal gripping portion.
The details of the distal outer tubular member 15 will be described below
in relation to the inner member 18.

[0031]The inner member 18 includes a proximal cylindrical portion 20, a
central cylindrical portion 22, a distal cylindrical portion 24, and a
plurality of longitudinal prongs 26. As shown in FIGS. 4-6, the proximal
cylindrical portion 20 has a greater diameter than the central and distal
cylindrical portions 22 and 24, while the distal cylindrical portion 24
has a greater diameter than the central cylindrical portion 22. The
distal outer tubular member 15 and the inner member 18 share a common
axis and are slidable relative to one another. The distal outer tubular
member 15 is positioned around the exterior of at least a portion of the
central cylindrical portion 22, distal cylindrical portion 24, and the
plurality of longitudinal prongs 26. The proximal gripping portion 16 of
the distal outer tubular member 15 is primarily located around central
cylindrical portion 22 and distal cylindrical portion 24.

[0032]The distal prong-engaging portion 17 of the distal outer tubular
member 15 is located around the plurality of longitudinal prongs 26. The
inner diameter of the distal prong-engaging portion 17 is configured to
be slightly larger than the outside diameter of the plurality of
longitudinal prongs 26 at the distal end of the prongs, but smaller than
the outside diameter of the plurality of longitudinal prongs 26 at the
proximal end of the prongs. Therefore, the axial sliding of the distal
outer tubular member 15 in the proximal direction (to the right in FIGS.
1-2) causes the inner diameter of the distal prong-engaging portion 17 to
interfere with the outer diameter of the plurality of longitudinal prongs
26. As the distal outer tubular member 15 is gradually slid farther in
the proximal direction, the inner diameter of distal tubular member 15
will squeeze against the longitudinal prongs 26 to force the prongs to
bend or compress toward each other. The bending and compressing narrows
the gap between the prongs 26, ultimately forcing prongs 26 against
guidewire 100 which is inserted inside a longitudinal passage 28 inside
steering device 12. The mechanical manipulation of the distal outer
tubular member 15 in the proximal direction will provide sufficient
gripping force to secure the steering device 12 and guidewire 100
together in fixed relation to one another so that guidewire 100 can be
steered through the human body. The manipulation of the distal outer
tubular member 15 in the distal direction will release the grip of the
longitudinal prongs 26 on guidewire 100, and allow for relative movement
between the steering device and guidewire 100.

[0033]The scope of the present invention includes types of guidewire
steering devices other than the torque-vise type device shown and
described. For example, many different torque devices, such as a pin-vise
with a chuck collet, exist where an outer member is rotated relative to
an inner member in order to tighten or widen a plurality of longitudinal
prongs similar to those shown in FIGS. 1-6. The type of torque device is
not essential as long as the torque device is configured for mating with
an alignment and connecting device of the present invention. Many torque
vises have an open area on the proximal end capable of accepting an
alignment and connecting device of the present invention.

[0034]The steering device of the present invention is configured for
mating with an alignment and connecting device as will be described
below. As shown in FIG. 6, the longitudinal passage 28 of the present
embodiment tapers to becomes progressively larger along the central
cylindrical portion 22 moving in the proximal direction (to the right in
FIG. 6). The longitudinal passage 28 includes a conical passage 30 inside
the central cylindrical portion 22. The conical passage 30 leads to a
proximal passage 32 adjacent the proximal cylindrical passage 20. The
proximal passage 32 includes a frustoconical section 33 at its most
distal end adjacent passage 30, and a cylindrical portion 34 at the
proximal end of section 33. Portion 34 includes a slight taper at a
proximal portion 36. The diameter of the proximal portion 36 increases
progressively towards the proximal end of the steering device 12. The
proximal passage 32 is configured to mate with an alignment and
connection tool, as will be described. It should be understood that the
scope of the present invention includes any suitable configuration for
mating the steering device with the alignment and connecting device is
acceptable.

[0035]In accordance with the present invention, the apparatus for steering
a guidewire and for connecting the guidewire to an extension guidewire
includes an alignment and connecting device. As embodied herein and shown
in FIGS. 1-2 and 7-10, an alignment and connecting device 14 for aligning
and connecting the guidewire to an extension guidewire is provided. The
connecting device 14 includes an attachment portion 50 configured for
attaching the connecting device 14 to the guidewire steering device 12 to
form a single unit, and an alignment portion 52 for aligning the
guidewire with an extension guidewire.

[0036]The attachment portion 50 of the connecting device 14 is configured
to mate with the proximal passage 32 of the guidewire steering device 12.
The attachment portion 50 is generally cylindrical shaped with two
cylindrical portions 54 and 56. The first cylindrical portion 54 extends
from the alignment portion 52 of the connecting device 14. The second
cylindrical portion 56 extends from the first cylindrical portion 54. In
the preferred embodiment, the second cylindrical portion 56 has a
slightly smaller diameter than the first cylindrical portion 54. The size
and shape of the attachment portion can be of any of a large variety of
sizes and shapes, as long as the attachment portion mates with a
corresponding portion of the steering device. The attachment portion 50
is preferably adhesive bonded to the proximal passage of the steering
device in order to provide a secure connection. Other acceptable
attachment methods include, but are not limited to, a solvent bond, spin
weld, vibration weld, and press-fitting. It is conceivable that a number
of different types of fasteners could also be utilized for attaching the
connecting device to the steering device.

[0037]The method for attaching the connecting device to the steering
device depends on a variety of design considerations, including the
materials that are used for the connecting device and steering device. In
a preferred embodiment, the connecting device and steering device are
both made out of nylon. Other acceptable materials include, but are not
limited to, high density polyethylene, ABS (acetyl butidene styrene),
various metals such as brass or stainless steel, and combinations of
metals and plastics such as using brass prongs in a steering device with
a plastic housing.

[0038]The connecting device 14 further includes an alignment portion 52.
The alignment portion includes a cylindrical portion 58 that is connected
to the attachment portion 50. In the embodiment shown in FIGS. 1-2 and
7-10, the diameter of the cylindrical portion 58 is greater than the
diameter of the adjacent first cylindrical portion 54 so that portion 58
rests against the proximal end of the steering device. The cylindrical
portion 58 of the attachment portion leads to a tapered portion 60. The
taper is in the form of radius of a circle of a given diameter. The
tapered portion 60 leads to substantially flat surface 62. The
substantially flat surface 62 is located on a cutaway portion of a
cylinder with an identical axis and diameter as the cylindrical portion
58 of the attachment portion 52. The substantially flat surface 62
extends along the axis of the attachment portion 52.

[0039]The connecting device 14 further includes a cylindrical longitudinal
passage 70 which passes through the first and second cylindrical portions
54 and 56 of the attachment portion 50 and through the cylindrical
portion 58 of the alignment portion 52. The longitudinal passage 70
begins at the distal end of the second cylindrical portion 56. The second
cylindrical portion 56 is provided with a first conical opening 72 for
the guidewire. The first conical opening 72 makes it easier for a
guidewire to be inserted into the longitudinal passage 70 if the
guidewire is slightly off center from the axis of the passage 70. The
conical opening 72 narrows as it progresses away from the distal end of
the attachment portion until the diameter of the opening 72 matches the
diameter of the longitudinal passage 70. It is desirable for the diameter
of the longitudinal passage 70 to be slightly larger than the largest
diameter of the in-situ guidewire and extension guidewire that will be
used.

[0040]The longitudinal passage 70 passes through the second cylindrical
portion 56 of the attachment portion 50, first cylindrical portion 54 of
the attachment portion 50, and cylindrical portion 58 of the alignment
portion 52. The longitudinal passage 70 then passes into the tapered
portion 60 and flat surface 62 as best shown in FIGS. 7-10. The passage
70 turns into a longitudinal slot after the tapered portion 74 of the
passage. The longitudinal slot includes a first slot 76 located adjacent
the tapered portion 74 and a second slot 78 located closer to the
proximal end of the alignment portion 52. In the preferred embodiment,
the longitudinal passage 70, tapered portion 74 of the passage, first
slot 76, and second slot 78 all share a common axis and have identical
diameters. Alternative embodiments for the longitudinal slots are
envisioned and will be discussed below.

[0041]As embodied herein and shown in FIGS. 7-10, the second longitudinal
slot 78 leads to a second conical opening 80 on the proximal end of the
alignment portion 52. The second conical opening 80 tapers outwardly in
order to facilitate insertion of the extension guidewire into the
connecting device 14. The second conical opening 80 allows for the
passage of the extension guidewire into the second longitudinal slot 78
even if the extension guidewire is slightly off center from the axis of
the slot.

[0042]As embodied herein and shown in FIGS. 2 and 7-10, a transverse
channel 82 is provided between the first longitudinal slot 76 and the
second longitudinal slot 78. The transverse channel 82 extends
perpendicular to the first and second longitudinal slots 76, 78. In the
preferred embodiment, the transverse channel 82 has walls of an identical
height, however, other configurations are within the scope of the
invention. In the preferred embodiment, the transverse channel 82 has a
depth greater than the depth of the longitudinal slots, however other
configurations may also be envisioned and still be within the scope of
this invention. The transverse channel serves several purposes. First,
the transverse channel 82 serves as a reference point so that it is clear
to the user where the connection between the in-situ guidewire and
extension guidewire should be made. Second, in an embodiment where the
walls of the transverse channel are of different heights, the higher wall
may serve as a stop for the main guidewire or extension guidewire as it
is inserted into the connecting device 14. This alternate embodiment will
be discussed in the paragraph below. Lastly, the transverse channel 82
provides an area in which the guidewire and extension guidewire may be
moved relative to one another to align with one another.

[0043]In one embodiment, the transverse channel has walls of differing
height. This configuration would be useful in an arrangement where the
main guidewire and extension guidewire have different diameters. The
longitudinal slot for the wire having the larger diameter will also need
to be of larger diameter. As the larger diameter wire is inserted into
the alignment tool along its corresponding longitudinal slot, it will
traverse the transverse channel and abut against the farthest vertical
wall of the transverse channel, thereby impeding movement of the larger
diameter wire. The end of the smaller guidewire can then be slid into the
end of the end of the larger diameter wire because the ends of the wires
are aligned.

[0044]Alternately, the transverse channel may be replaced by a simple
straight line marked on the top of the flat surface where the transverse
channel was previously located. This straight line will serve as a
reference point for the operator. The operator can use the straight line
as the point at which the guidewire should not be inserted any further
into the alignment and connecting device. In an additional embodiment,
the transverse channel consists of a slot with an identical depth as the
first and second longitudinal slots.

[0045]A variety of different types of guidewires and extension guidewires
may be used with the present invention. An exemplary type of extension
guidewire connection is shown, for example, in U.S. Pat. No. 5,133,364,
to Palermo et al., the complete disclosure of which is hereby
incorporated by reference herein. U.S. Pat. No. 5,133,364 describes the
extension guidewire connection in greater detail. In a preferred
embodiment of the present invention, the main guidewire and extension
guidewire have identical diameters. As described in U.S. Pat. No.
5,133,364, the proximal end of the main guidewire may be fitted with a
tubular member having approximately the same outside diameter as the
guidewire. The tubular member will be referred to as a hypotube because
it is typically formed from commercially available hypodermic tubing. The
hypotube typically has a wall thickness of the order of 0.003'' and
defines a cylindrical internal socket. The hypotube is considered to be
part of the main guidewire because it is essentially permanently attached
to the proximal end of the main guidewire. The hypotube is typically
welded, bonded, or brazed to the main guidewire. Other suitable
attachment methods are also acceptable.

[0046]In a preferred type of extension guidewire, the distal end of the
extension guidewire has a smaller diameter than the remainder of the
extension guidewire, and is provided with a helical coil on this smaller
diameter portion, as also described in U.S. Pat. No. 5,133,364. The outer
diameter of the helical coil is equal to or just slightly greater than
the inner diameter of the cylindrical internal socket of the hypotube.
This provides a light interfering fit with the socket. The main guidewire
and extension guidewire are connected by inserting the distal end of the
extension guidewire into the cylindrical internal socket of the main
guidewire and twisting. The extension guidewire can be inserted into the
guidewire as described in U.S. Pat. No. 5,133,164. The friction fit
between the helical coil and the internal socket can withstand a
relatively large amount of axial tension without becoming disconnected.
However, the extension guidewire can be easily disconnected by simply
twisting the extension guidewire in the appropriate direction.

[0047]The mating ends of the main and extension guidewires may take a
variety of other structural forms known in the art and still be within
the scope of the present invention. The invention is not limited by the
particular guidewire and, particularly, the particular guidewire
structure for connecting the ends. For example, the extension guidewire
can be press-fit into a cylindrical opening in the main guidewire.
Alternately, the proximal end of the main guidewire and the distal end of
the extension guidewire may be provided with mating geometrical shapes
such as hexagon ends.

[0048]The method of steering the guidewire and connecting the main
guidewire to an extension guidewire of the present invention will now be
described. The method of the present invention is useful in a wide
variety of medical procedures, including, for example, vascular
applications such as angioplasty and nonvascular applications such as a
biliary procedure. Other procedures include cardiology procedures such as
stent placements, neuro-radiology procedures such as placement of coils,
and urological procedures such as a catheter placement to remove stones.
In a biliary procedure, for example, a cannula is passed through the
mouth into the common bile duct. The present invention can be used, for
example, to insert balloon or basket catheters to remove gallstones.

[0049]The main guidewire may be steered into place in a lumen of the body
by placing the guidewire through the steering device 12 of the apparatus
10. While gripping the guidewire, the steering device can be manipulated
to change the angle and speed of entry into the body. If the guidewire
has an angled tip, the guidewire can be rotated in order to change the
direction that the guidewire will follow in the body. The guidewire is
then fed from the steering device 12 by a progressive gripping and
releasing of the distal end of the steering device 12. Each gripping and
releasing will advance the guidewire slightly farther into the body. An
initial guide catheter may already be inserted in the body, or the
catheter may be inserted over the guidewire after the guidewire has
obtained the desired position. Once a catheter is in place and it is
desirable to remove the catheter to replace it with another catheter, an
extension guidewire can be connected to the in-situ guidewire.

[0050]An extension guidewire may be attached to the guidewire as follows.
First, the apparatus 10 is moved proximally along the guidewire so that
it is positioned on the proximal end of the in-situ guidewire. The
in-situ guidewire is arranged so that the proximal end of the in-situ
guidewire passes through the longitudinal passage 28 of the steering
device 12 and the longitudinal passage 70 of the connection device 14.
The apparatus 10 then is slid until the proximal end of the in-situ
guidewire is lined up with the transverse channel 82. If the transverse
channel 82 has walls of varying height, the proximal end of the in-situ
guidewire can be positioned so that it is flush with the wall adjacent
the second longitudinal slot 78.

[0051]The steering device 12 is then clamped onto the main guidewire and
the extension guidewire is inserted into the second conical opening
opening 80 of the connection device 14. The extension guidewire is slid
along the second longitudinal slot 78 until the distal end of the
extension guidewire abuts and is inserted in the proximal end of the main
guidewire, or attached to the main guidewire by another method.

[0052]After the extension guidewire is connected to the main guidewire by
the appropriate method, the steering device 12 may be released so that it
no longer firmly grips the main guidewire, and the apparatus 10 can be
slid off of the main guidewire and extension guidewire. The existing
catheter can then be removed by pulling the catheter over the length of
the main guidewire and extension guidewire. A new catheter may then be
inserted by pushing the new catheter over the length of the extension
guidewire and main guidewire. The extension guidewire can then be
disconnected. In order to disconnect, the apparatus 10 can be fed over
the length of the extension guidewire to the point just before the
connection. The main guidewire is held firm. The apparatus 10 can then be
used to grip the extension guidewire so that the extension guidewire can
be rotated relative to the main guidewire. The above steps can be
repeated in order to exchange a plurality of catheters.

[0053]It will be apparent to those skilled in the art that various
modifications and variations can be made in the apparatus and method for
steering a guidewire and for connecting a guidewire to an extension
guidewire, use of the apparatus of the present invention, and in
construction of this apparatus, without departing from the scope or
spirit of the invention.

[0054]Other embodiments of the invention will be apparent to those skilled
in the art from consideration of the specification and practice of the
invention disclosed herein. It is intended that the specification and
examples be considered as exemplary only, with a true scope and spirit of
the invention being indicated by the following claims.

Patent applications by Peter A. Hamilton, East Bridgewater, MA US

Patent applications in class Body entering conduit axially movable within body piercing conduit while former is disposed in the body

Patent applications in all subclasses Body entering conduit axially movable within body piercing conduit while former is disposed in the body